Role of Industry in Long-term Management of Disused Radioactive Sealed Sources

1. Role of Industry in Long-term Management of Disused Radioactive Sealed Sources Name: Paul Gray Company: Chairman; ISSPA (International Source Suppliers and Producers Association) Vice President; External Relationships and Global Logistics, Nordion Inc. (retired) IAEA Workshop on Cradle to Grave Control System; March, 2017

2. Medical treatment, diagnostics, therapeutics and palliation : cancer treatment (>4500 treatments/day in > 50 countries) : 750 Cs-137 blood irradiators in > 50 countries) Sterilization of single-use medical products (>45%) Food safety and agricultural applications Process control Industrial and safety applications (NDT of welds, pipelines, castings, engines, bridges, infrastructure, etc.) Research and development Nuclear Energy Electronics components (tantalum/niobium) Law enforcement & counterterrorism The radioisotope sector is broad and diverse, long established, with a culture of safety and security Radioactive Sealed Sources – Critical to Global Economy & Health

3. ISSPA (International Source Suppliers and Producers Association) Overview 16 members from 8 countries Industry leaders ensuring the safe and secure design, manufacture, supply and life management of radioactive sources and equipment. Collectively, produce a significant proportion of all sealed sources globally Its mission is to ensure the use of radioactive sources continues to be regarded by the public, the media, legislators, and regulators as beneficial Approximate 5% growth in sources for sterilization industry per year Approximate 2 – 3% growth in industrial radiography sources per year Major areas of growth primarily in regions of world where health care funding and increased access to health care and infrastructure growth are occurring

4. ISSPA (16 Members – 8 Countries) • Alpha Omega Services • Berthold Technologies GmbH & Co. KG • Best Theratronics Ltd • Dioxitek S.A./CNEA • Eckert & Ziegler Nuclitec GmbH • Endress + Hauser GmbH + Co. KG • Gamma-Service Recycling GmbH • Hopewell Designs • Institute of Isotopes, Co. Ltd. • International Isotopes Inc. • Nordion Inc. • NTP Radioisotopes • QSA Global Inc • Source Production & Equipment • Varian Brachytherapy • RAIMS

5. ISSPA Overview Effective source management practices are a cornerstone to strengthen the long term safety and security of radioactive sources throughout their life cycle. Radioactive sources are a safe, secure, viable technology for use in a wide variety of important medical, industrial, and research applications. In many cases, source technology is the best, and often only technology capable of meeting healthcare, consumer and industry needs Highly regulated industry and our Association’s Code of Practice uses the regulations as a minimum standard Exemplary safety and security record Effective life-cycle management activities to minimize the amount of unused material in circulation and avoid loss of control ISSPA aims to ensure the ongoing and beneficial use of radioactive isotope sealed sources and promotes continuous improvements in the safe and secure use, transportation and end of life management of sealed sources ISSPA addresses a number of industry-critical concerns including safety, security, lifecycle management, denial of shipments, isotope supply and transportation

6. A Source Life Cycle Management Model(integrated approach) Safe & Secure Use of Radioactive Sources Safe & Secure Use of Radioactive Sources Competent National Authorities and Regulatory Infrastructure Qualified and Responsible Manufacturers and Suppliers Licensed and ResponsibleUsers IAEA Guidelines, Code of Conduct

7. Cradle-to-Grave Source Management Isotopes from reactor Supplier Interim Storage Source manufacturing End-of-Life Management Export to end-user Return to Supplier/other (5-30 years later)

8. Source Management Concept of Return to Original Manufacturer It is industry’s position that a sealed source could and should be returned to any willing source manufacturer capable of safely handling and managing it. Ideally & most cost effectively) disused sources would be transferred to supplier of the new source (new source may not be produced by original manufacturer of the disused source) This position also addresses issues that arise when the original source manufacturer is no longer in business or no longer authorized to possess the source

9. Strategies - Long Term Management of DSRS Recycle Long Term Storage Disposal

10. Recycle – Reutilization of Resources Industry’s Preferred Option Responsible end-of-life management Reduces the amount of radioactive material that needs to be produced (and ultimately, disposed of) … utilizes an existing resource Most cost effective : 1 for 1 exchange : container/personnel /equipment on site : where a source is contained in a device, the end user has an incentive to return the device with the old source when having it reloaded : minimizes transport costs Various methods available Addresses some of the disposal challenges – disposal site, transport container's, disposal packages and costs

11. Recycle – “Re-Life” the Source Reutilize the source “as-is” • Inspection and Testing required for each source • Extends working-life (RWL already found to be greater than predicted with many sources – often doubled) Re-encapsulation and Over - encapsulation • Remove and replace outer encapsulation, or • Over encapsulate entire source, use for new application (may involve device re-design / re-construction)

12. Recycling Results Millions of Curies of Co-60 have been recycled One supplier program currently recycles 15% of Cs-137 sources provided to a gauge manufacturer One supplier of Co-60 has recycled > 1 MCi in past decade Several suppliers recycle AmBe sources (oil well logging, gauging, thickness measurement) , reducing the need for disposal of very old sources Changes to device to accommodate different sources, gauge manufacturers involved and new licensing

13. End-of-Life Management Interim Storage is part of End-of-Life Management Interim Storage is not Storage prior to final disposal Not the first but the last option Dispose Reuse Recycle (recover material) Transfer to another Manufacturer (“re-use”) Re-encapsulate (“re-life”)

14. Long Term Storage of DSRS Less Preferred Option Source manufacturers have robust security controls so LTS at the source manufacturer facility is feasible but limited by licencing and physical capacity Must consider: - Potential alternative applications (recycle/ “relife”) - Facility / site licence conditions and limits - Liability issues associated with quantities possessed - Costs for return of sources to manufacturer - End user must have funds for source return - Ultimate disposal path must be available - Financial responsibility of eventual disposal

15. End of Life Considerations Some sealed sources may be able to be returned to any capable source manufacturer regardless of country of origin Original manufacturers willing to take back sources they produce, liability risk is significant for other’s sources This position also addresses issues that arise when the original source manufacturer is no longer in business • One-for-One source exchange limits the number of disused sources that may otherwise be abandoned. Also a cost effective way of getting a disused or spent source returned to the manufacturer. Industry continually increases their activities to recycle sources as an alternative to disposal • Cannot estimate disposal costs at time of manufacture – financial assurance . Manufacturers are reluctant to take on incalculable financial liabilities taking title to disused sources that they may not be able to recycle or dispose • Few Member States have a repository / disposal infrastructure in place (Guidance: Section 18)

16. Considerations or Challenges for Long Term Management of DSRS 1. Recycling in the context of regulatory constraints restricting the international shipment of materials that could be misconstrued as waste. Used sources should be regarded as “materials” easing international shipments and should not be considered waste until they go to final disposal repository (Guidance: section on long-term management of DSRS Within Radioactive Waste Management) 2. Containers – to be discussed 3. Regulatory Consistency : Regulatory constraints and high cost of repackaging & shipping sources with expired regulatory documentation (Special Form, Type Betc) Expedient procedures for authorizing “special arrangements” would ease/encourage return shipments of sources with expired regulatory documentation - Risk / Benefit assessment of regaining control (Guidance: Sections 26 and 30) 4. Transportation – to be discussed

17. Challenges – Containers Lack of containers does result in an increase in transportation costs but the limited availability has far reaching consequences that introduce additional barriers in the over all scheme of DSRS management

18. Challenges – Containers (Cont’d) Device Specific Containers: Many containers were built for a specific device or source. The container may no longer be certified and/or the device is obsolete. The cost associated with developing a container to transport the specific device is not commercially viable. Authorized Contents : Most containers are dedicated for transporting sealed sources in Special Form. A good proportion of DSRS have either lost Special Form certification or can only be linked to such. Availability : Type B(U) packages are not universally accepted (no reciprocity in certifications)

19. Challenges – Regulatory Infrastructure Increased regulatory burden exacerbated by competing / conflicting regulatory agencies and regulations (international inconsistencies) Standardized or harmonized regulations would ease international movement of disused sources(Guidance: Section 30) • Prevents lapse of Special Form and Type B certifications. Seamless revalidations of Type B(U) Package Certificates supports the movement of new and disused sources • Need Regulatory Authority support / approval

20. Some practical distribution challenges throughout the world due to concerns about radiation and due to restrictions arising from the changing global economy Limited supply chain : carriers, Ports & containers = high potential costs (supply / demand economics). Industry needs to integrate with supply chain. Regulatory requirements shall not be a barrier to companies wanting to enter RAM transport market (Guidance: Sections 5, 25 – 29 ) Increased regulatory burden (tracking, security, financial surety) exacerbated by competing/conflicting regulatory agencies and regulations. Industry / regulators need to integrate Denials of shipment due to carrier, route, Port and supply chain restrictions; due to reluctance to handle Class 7. Need facilitation where possible (Guidance : Sections 27 – 29) Challenges - Transportation

21. Challenges – Transportation The cost associated with transferring a new source from the manufacturer to the end user is a significant fraction of the total expense A similar cost would be associated with transporting a disused source back to the manufacturer (i.e. benefits of 1 : 1 transfers) It is safe to assume that this cost discourages some end users from returning sources to the manufacturer

22. Challenges - Financial Industry can’t estimate disposal or transportation costs for source users at time of purchase when sources have a multi-year life (e.g. Co-60 = 20+ yrs) Reasons : too many unknowns – site availability / access; disposal costs; inflation; transportation capability; special arrangement option/cost if applicable; DSRS quality; end user licencing; regulatory requirements / costs; etc. Can estimate transport costs out 1 year maximum but can update annually If MS has a disposal facility (Guidance ; Sections 18, 19), that facility can identify associated costs for disposal – provides known financials and potential, marketing and competitive rates Contract management issue between supplier / user

23. Disposal Not a viable option through a source manufacturer Source manufacturers do not operate as waste brokers Licensing and regulatory restrictions would greatly limit this Disposal site availability may also be limited by legislatively imposed restrictions ( i.e. waste generator or country of origin restrictions)

24. Disposal How important is availability of disposal infrastructure in providing options to users and suppliers for safe and secure source management? • Radioactive sources and materials have a niche which facilitates many necessary industrial, medicinal and research uses and currently cannot be replaced by alternative technologies. • Industry’s hands are tied. Disposal of radioactive material is politically driven, with science taking a back seat. • Why at the most vulnerable stage in the life cycle are there so few options to properly manage a source that has no effective use? • A disposal infrastructure is VITAL to ensure safety and security throughout the entire life cycle of a sealed source (Guidance : Sections 17 -19)

25. What is the role of key stakeholders in this initiative? The Member State – develop disposal capability; log term strategy, disposal facility, required infrastructure (Guidance: Sections 4-12; 16-21; 25-30) Regulator : develop, realistic , consistent and harmonized regulations that are designed to ensure the safety and security of radioactive sources throughout the life-cycle that do not jeopardize the beneficial use of radioactive sources or materials. Will include containers; licencing; Special Arrangements (Guidance: Sections 10, 13, 14, 24-30) The Supplier and Producer – Manufacture, deliver and provide end of life management services that emphasize safety and security and are in compliance with all applicable regulations. Will include licence limits; robust safety and security programs; current equipment and experts (Guidance: Sections 12, 15, 17, 25, 27) The User – Utilize and maintain radioactive sources and devices in a safe and secure manner, in compliance with applicable regulations, throughout the useful life. When the source or device is no longer in use, ensure that safety and security are maintained until the source is transferred to a responsible party (Guidance: Sections 11, 12, 15, 17)

26. Conclusion Radioactive sources can and will provide a safe, secure, viable technology for medical, industrial, and research applications for decades to come. Regulators, Suppliers/Manufacturers, and Users have overlapping and distinct responsibilities in regards to safety and security throughout the entire source life cycle. Disposal options for disused radioactive sources must be commercially and readily available.

27. Conclusions and Next Steps Radioactive sources can and will provide a safe, secure, viable technology for medical, industrial, and research applications for decades to come Regulators, Suppliers/Manufacturers, and Users have overlapping and distinct responsibilities in regards to safety and security throughout the entire source life cycle Recycling sources serves as a critical and effective means to end of life management One-for-one source exchanges and recycling initiatives should be encouraged Seamless revalidations of Type B(U) Package Certificates supports the movement of new and disused sources Harmonization of applicable regulations Practical financial issues need to be addressed in dealing with end-of-life management Sealed sources should not be considered a waste until they move to the final disposal repository Ultimate disposal of disused sources needs to be addressed. Disposal options for disused radioactive sources must be commercially and readily available ..

28. Engagement of Industry: a Key Success Factor to Enhance Safety and Security Culture in DSRS Management To actively participate in developing strategies for the long term control and management of sources. To collaborate with the IAEA in developing international policy matters To forge a strong partnership with national legislators and regulators To develop comprehensive standards that facilitate global commerce To facilitate communication, education, and awareness amongst key stakeholders  as an industry, we take seriously our responsibility to ensure effective stewardship and self-management of our industry

29. Thank you • Questions?